The previous studies showed that the early diagnosis is the best strategy for increasing of the survival of gastric cancer patients. Therefore, investigating of insulin-like growth factor I and its related signaling pathways can significantly improve to early detection of gastric cancer and its treatment. The present study includes 75 patients (40-70 years) with dyspepsia who refer to Imam Khomeini and Rasool-e Akram hospitals from September 2016 until September 2017. The patients will be divided into two groups: non-gastric and gastric cancer patients. Then, 10 cc whole blood and the tumor tissue sample of all the patients will collect under endoscopy procedure. RNA extraction, cDNA synthesis and the quantitative analysis for the genes expression will perform. Evaluations include Helicobacter pylori, gastritis grades, and histopathological assay. In addition, the different stages of gastric cancer according to international system of TNM, serum level of IGF1 and the expression of genes involved in insulin-like growth factor 1 signaling pathway will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080318745N10
Registration date:2016-08-30, 1395/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-30, 1395/06/09
Registrant information
Name
Ali Mohammad Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2501
Email address
aalizadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Iran University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of insulin-like growth factor I and its signaling pathways in the serum and the tissue of gastric cancer patients
Public title
Assessment of serum level of insulin-like growth factor 1 in the Blood of gastric cancer patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria include: 40-70 years old patients with dyspepsia; the patients with written consent; the patients with no history of cancer or special disease.
Exclusion criteria include: the patients with diabetes type 1 or 2; the patients with obesity; the patients with smoking.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Bulvar, Porsina Street
City
Tehran
Postal code
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
IR.TUMS.REC.1395.2261
Health conditions studied
1
Description of health condition studied
Gastric cancer
ICD-10 code
C16.9
ICD-10 code description
Stomach, unspecified
Primary outcomes
1
Description
Serum level assessment of insulin-like growth factor I
Timepoint
after endoscopy procedure
Method of measurement
Elizza
Secondary outcomes
1
Description
the expression of the genes involved in insulin-like growth factor 1 signaling pathway
Timepoint
One time after sampling
Method of measurement
Real-time PCR
Intervention groups
1
Description
The patients with dyspepsia will be divided into two groups: non-gastric and gastric cancer. After inclusion, 10 cc of whole blood and the tumor tissue sample of all the patients under endoscopy will be collected.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Research Center, Cancer Institute of Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Hospital Rasool Akram
Full name of responsible person
Dr. Shahram Agah
Street address
Hospital Rasool Akram, Mansori St., Niayesh St., Sattarkhan St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Uonesian
Street address
Keshavarz Bulvar, Porsina Street.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mousavi
Street address
Fifth Floor, Iran University of Medical Sciences Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Cancer Research Center, Cancer Institute of Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6119 2501
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
www.pccrg.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cancer Research Center, Cancer Institute of Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6119 2501
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
www.pccrg.org
Person responsible for updating data
Contact
Name of organization / entity
Cancer Research Center, Cancer Institute of Iran
Full name of responsible person
Dr. Ali Mohammad Alizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
3rd Fl. of Radiotherapy Bldg, Cancer Institute, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6119 2501
Fax
Email
aalizadeh@sina.tums.ac.ir
Web page address
www.pccrg.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)